Trials / Completed
CompletedNCT03718208
Acceptability and Tolerance Study of a Low Calorie Peptide Based Paediatric Tube Feed Formula.
To Evaluate the Acceptability (Including Gastro Intestinal Tolerance and Compliance) of a Low Calorie Peptide Based Paediatric Tube-feed Formula; for Children Greater Than 1 Year of Age.
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 15 (actual)
- Sponsor
- Société des Produits Nestlé (SPN) · Industry
- Sex
- All
- Age
- 1 Year – 15 Years
- Healthy volunteers
- Not accepted
Summary
This is an acceptability study to evaluate the gastrointestinal tolerance and compliance over a seven-day period, of a low calorie paediatric peptide based tube feed formula for the dietary management of participants with short bowel syndrome; intractable malabsorption; preoperative preparation of undernourished patients; inflammatory bowel disease; total gastrectomy; dysphagia; bowel fistulae; The acceptability data from 15 participants will be collected in order to submit an application to the Advisory Committee on Borderline Substances (ACBS).
Detailed description
Patients well established and stable on a standard or peptide enteral tube feed will be changed to a low calorie paediatric formula for a period of seven days. This group will act as their own controls. Each child will receive for a period of seven days the paediatric formula. The dietitian will determine the feeding regimen on an individual basis and the enteral formula will be provided via a feeding tube. A baseline questionnaire will be completed by the dietitian to ensure eligibility of study, current stool patterns or symptoms and weight at the start of the study. The parents will complete a week intake chart to monitor how much feed has been consumed each day and a tolerance diary to review gastrointestinal symptoms at the start and end of the study.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | Paediatric Formula | Children will switch over to the low calorie paediatric feed. Intake diaries and tolerance diaries will be completed for one week. |
Timeline
- Start date
- 2018-08-08
- Primary completion
- 2019-07-22
- Completion
- 2019-07-22
- First posted
- 2018-10-24
- Last updated
- 2020-08-19
Locations
3 sites across 1 country: United Kingdom
Source: ClinicalTrials.gov record NCT03718208. Inclusion in this directory is not an endorsement.